[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520923":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":33,"locations":43,"responsibleParty":63,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":18,"eligibilityCriteria":75,"healthyVolunteers":72,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":18,"overallStatus":46,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Endeavor Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"adalimumab","ACTIVE_COMPARATOR","adalimumab 40 mg every 2 weeks",[13],"Drug: Adalimumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","NO_INTERVENTION","placebo injection (saline) every 2 weeks.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Adalimumab","Adalimumab will be delivered subcutaneously (under the skin) at a dose of 40mg every 2 weeks for a total of 6 doses.",[9],[26],"Placebo will be administered subcutaneously every 2 weeks, for a total of 6 injections.",[28,31],{"name":29,"affiliation":5,"role":30},"Simon W Hayward, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":5,"role":30},"Alexander P Glaser, M.D.",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":38},"Malgorzata Antoniak, Ph.D.","CONTACT","847-503-4282","MAntoniak@northshore.org",{"name":40,"role":36,"phone":41,"phoneExt":18,"email":42},"Pooja Talaty, MS MHA CCRP","847-503-4280","PTalaty@northshore.org",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"NorthShore University HealthSystem","RECRUITING","Glenview","Illinois","60026","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-87.78784,42.06975,{"lat":56,"lon":55},[59,60,62],{"name":40,"role":36,"phone":41,"phoneExt":18,"email":42},{"name":61,"role":36,"phone":18,"phoneExt":18,"email":18},"Simon W Hayward, Ph.D",{"name":32,"role":36,"phone":18,"phoneExt":18,"email":18},{"type":30,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Alexander Glaser","M.D.; Clinical Assistant Professor University of Chicago Pritzker School of Medicine",[67],{"name":68,"class":69},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100520923","phase-2-effects-of-tnf-blockade-on-human-bphluts-100520923",false,"NCT06062875","Effects of TNF Blockade on Human BPH\u002FLUTS","Inclusion Criteria:\n\n* Male sex\n* Age 45-80 years\n* Diagnosed by physician with BPH\n* Prostate volume ≥ 60mL\n* IPSS ≥ 8\n* Able and willing to complete questionnaires\n* Able and willing to provide informed consent\n* Able to read, write, and speak in English\n* No prior treatment with TNF inhibitor (adalimumab, etanercept, infliximab, certolizumab, golimumab)\n* No plans to move from study area in the next 6 months\n\nDeferral Criteria:\n\n* Microscopic hematuria without appropriate workup per AUA\u002FSociety of Urodynamics, Female Pelvic Medicine \\& Urogenital Reconstruction (SUFU) Guidelines\n* Positive urine culture\n\nExclusion Criteria:\n\n* Female sex or intersex\n* Age \\\u003C 45 or \\> 80 years\n* Being a prisoner or detainee\n* Urinary retention with need for catheterization\n* Gross hematuria\n* Contraindication to treatment with adalimumab (e.g., presence of sepsis or active infection, active tuberculosis, Hepatitis B infection, invasive fungal infection, lymphoma, leukemia or other active malignancy, congestive heart failure, significant hematologic abnormality, allergy to adalimumab or its components, anti-drug antibodies, congestive heart failure)\n* Diagnosis of autoimmune disease (rheumatoid arthritis, plaque psoriasis, ulcerative colitis, Crohn's disease, hidradenitis suppurativa, spondyloarthritis)\n* Interstitial cystitis\n* Pelvic or endoscopic genitourinary surgery within the preceding 6 months (not including diagnostic cystoscopy)\n* History of lower urinary tract or pelvic malignancy including prostate cancer; history of pelvic radiation therapy\n* Ongoing symptomatic urethral stricture\n* Current chemotherapy or other cancer therapy\n* Severe neurological or psychiatric disorder that would prevent study participation (e.g., bipolar disorder, psychotic disorder, Alzheimer's Disease)\n* Current moderate or severe substance use disorder","MALE","45 Years","80 Years",{"count":80,"type":81},70,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","Specific Aim 1. To evaluate the efficacy of TNF antagonist action in BPH\u002FLUTS Specific Aim 2. Define the consequences of TNF antagonist therapy on prostate tissue Specific Aim 3. Identify genetic predictors to stratify patients with differential response to TNF-antagonist therapy.",[87],"Benign Prostatic Hyperplasia (BPH)","2024-11-18",{"date":90,"type":91},"2024-11-21","ACTUAL",{"date":93,"type":91},"2024-01-24",{"date":95,"type":81},"2028-06-01",{"name":5,"class":6},1]